Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01597908
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Dabrafenib 150 mg twice daily orally
  • Vemurafenib — DRUG
    Vemurafenib 960 mg twice daily orally
  • Trametinib — DRUG
    Trametinib 2 mg once daily orally

Study Details

This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

Key Dates

Start date
Jun 4, 2012
Status verified
Feb 2021
Primary completion
Apr 17, 2014
Completion
Apr 25, 2019

Study Design

Enrollment
704 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib plus Trametinib
    BRAF inhibitor plus MEK inhibitor
  • Active Comparator: Vemurafenib
    BRAF inhibitor

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From the date of randomization until date of death due to any cause (up to approximately 6 years) ]

Locations (36)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35243-
Novartis Investigative SiteGilbertArizona85234-
Novartis Investigative SiteBeverly HillsCalifornia90211-
Novartis Investigative SiteSan FranciscoCalifornia94115-
Novartis Investigative SiteVallejoCalifornia94589-
Novartis Investigative SiteAuroraColorado80010-
Novartis Investigative SiteJacksonvilleFlorida32204-
Novartis Investigative SiteMiami BeachFlorida33140-
Novartis Investigative SiteOrlandoFlorida32804-
Novartis Investigative SiteAtlantaGeorgia30322-
Novartis Investigative SiteAtlantaGeorgia30341-
Novartis Investigative SiteIowa CityIowa52242-
Novartis Investigative SiteAnn ArborMichigan48109-
Novartis Investigative SiteFridleyMinnesota55432-
Novartis Investigative SiteSt LouisMissouri63110-
Novartis Investigative SiteLas VegasNevada89148-
Novartis Investigative SiteHackensackNew Jersey07601-
Novartis Investigative SiteNew BrunswickNew Jersey08901-
Novartis Investigative SiteNew YorkNew York10029-
Novartis Investigative SiteChapel HillNorth Carolina27599-7600-
Novartis Investigative SiteCharlotteNorth Carolina28204-
Novartis Investigative SiteDurhamNorth Carolina27710-
Novartis Investigative SiteCincinnatiOhio45219-
Novartis Investigative SiteColumbusOhio43210-
Novartis Investigative SiteBendOregon97701-
Novartis Investigative SitePortlandOregon97213-
Novartis Investigative SitePortlandOregon97239-
Novartis Investigative SiteCharlestonSouth Carolina29425-
Novartis Investigative SiteGreenvilleSouth Carolina29605-
Novartis Investigative SiteNashvilleTennessee37232-
Novartis Investigative SiteDallasTexas75246-
Novartis Investigative SiteSalt Lake CityUtah84106-
Novartis Investigative SiteSalt Lake CityUtah84112-5550-
Novartis Investigative SiteBurlingtonVermont05403-
Novartis Investigative SiteCharlottesvilleVirginia22903-
Novartis Investigative SiteMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Novartis Investigative Site· Birmingham, ALNovartis Investigative Site· Gilbert, AZNovartis Investigative Site· Beverly Hills, CANovartis Investigative Site· San Francisco, CANovartis Investigative Site· Vallejo, CANovartis Investigative Site· Aurora, CO

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